Kornimate/medical-research-clean huggingface dataset:
verification of shear wave elastography for detection of prostate cancer

Conditions: Prostatic Neoplasms

Summary: 1. objective to provide evidence that adding shear wave elastography during sono-guided prostate biopsy can increase prostate cancer detection rate and to demonstrate that shear wave elastography of the prostate can discriminate malignant lesions to reduce the number of unnecessary prostate biopsies. 2. overview patients who are indicated for prostate biopsy in suspicion of prostate cancer will be assigned to a control group and an intervention group under double blinded randomization. * control group : patients will undergo prostate biopsy guided by conventional ultrasonography (b mode, gray scale). * experimental group : patients will undergo prostate biopsy guided by shear wave elastography in addition to conventional ultrasonography. a comparative statistical analysis of the two groups will be performed. the study is planned to be conducted for 3 years, with 2 years for patient enrollment and 1 year of follow-up. three hospitals will participate in the study to enroll 85 patients for each group and a total of 170 patients. 3. inclusion and exclusion criteria * male patients with suspected prostate cancer must meet at least one of the following three criteria. 1. psa level over 4ng/dl 2. suspicious hard prostatic nodule on digital rectal examination. 3. hypoechoic lesion on ultrasound of the prostate suspicious for cancer. * patients who (1) are less than 20 years old, (2) have a history of surgery on the prostate such as holep, (3) have moderate cognitive impairment, or (4) have medical conditions precluding transrectal procedures such as rectal cancer are excluded from the study. 4. research method * patients who wish to participate in this study and meet the inclusion/exclusion criteria are randomly assigned to the 2 groups as described above. * the biopsy results are checked one week after the procedure. * patients confirmed to have prostate cancer are provided proper treatment according to generally accepted treatment methods. * patients with negative biopsy results are followed according to general follow-up protocol for suspected prostate cancer patients. after 6 months from the biopsy the patients are re-evaluated and if cancer is still suspected based on psa level or other clinical symptoms, prostate mri or additional biopsy is be performed. * patients are followed again after 12 months since the initial biopsy with identical methods from the 6 months follow-up protocol.


Eligibility criteria:
inclusion criteria: 1. psa level over 4ng/dl 2. suspicious hard prostatic nodule on digital rectal examination. 3. hypoechoic lesion on ultrasound of the prostate suspicious for cancer. exclusion criteria: 1. less than 20 years old 2. history of surgery on the prostate such as holep 3. more than moderate cognitive impairment which limits understanding of the study 4. medical conditions precluding transrectal procedures such as rectal cancer
pilot study to investigate the efficacy of a toothpaste in providing relief from dentinal hypersensitivity

Conditions: Dentinal Sensitivity; Hypersensitivity

Summary: a pilot study to determine the ability of a stannous fluoride containing toothpaste to provide immediate and short term relief from dentine hypersensitivity compared to a control toothpaste.


Eligibility criteria:
inclusion: * self-reported history of dentinal hypersensitivity lasting more than 6 months and less than 10 years * teeth showing signs of facial/cervical gingival recession and/or signs of erosion or abrasion. * teeth having a gingival index score of less than or equal to 1 * teeth with a clinical mobility less than or equal to 1 * sensitive teeth from those meeting the ear, gi and mobility criteria at screening, with sensitivity as measured by tactile stimulus (yeaple probe, tactile threshold 10g) and evaporative (air) stimulus (schiff sensitivity score ≥ 2). exclusion: * presence of chronic debilitating disease which could affect study outcomes. * any condition which causes xerostomia. * dental prophylaxis within 4 weeks of screening. * tongue or lip piercing or presence of dental implants. * professional desensitising treatment within 12 weeks of screening. * gross periodontal disease, treatment of periodontal disease (including surgery) within 12 months of screening, scaling or root planning within 3 months of screening. * teeth bleaching within 12 weeks of screening. * tooth with evidence of current or recent caries, or reported treatment of decay in 12 months of screening. * tooth with exposed dentine but with deep, defective or facial restorations, teeth used as abutments for fixed or removable partial dentures, teeth with full crowns or veneers, orthodontic bands or cracked enamel. sensitive teeth with contributing aetiologies other than erosion, abrasion or recession of exposed dentine, or not expected to respond to treatment with an over-the counter dentifrice. * daily doses of a medication which could interfere with the perception of pain. * currently taking antibiotics or have taken antibiotics within 2 weeks of baseline. * individuals who require antibiotic prophylaxis for dental procedures.

Keywords: dentinal hypersensitivity
metabolic control and patient well-being in phenylketonuria: do guidelines make a difference?

Conditions: Phenylketonurias

Summary: treatment of pku implies for most patients that with strict adherence to dietary treatment they can achieve excellent neurocognitive outcome. dietary treatment, though, is hard to comply to every day and with every single meal. unsurprisingly, health-related quality of life (hrqol) is negatively affected if patients have to follow a dietary regime of this kind. adherence to treatment in pku is very variable. factors of significant impact on adherence to treatment and well-being in chronic disease such as self-efficacy or parenting stress have not yet been widely investigated in pku patients. the ideal treatment prescription (and guideline) recommends as much as necessary and as little as possible, based on the best evidence available. patients should neither be deprived of treatment options nor be exposed to overtreatment. this study investigates adherence, metabolic control, hrqol in pku patients treated by centres which follow different guidelines


Eligibility criteria:
inclusion criteria:- patients with pku from age 10 years requiring dietary and / or pharmacological treatment according to locally applied guidelines * parents of patients with pku aged 10 to 18 years requiring dietary and / or pharmacological treatment according to locally applied guidelines * ability and willingness to answer the questionnaires and follow the study procedures * informed consent as documented by signature exclusion criteria for patients and parents : * inability to follow the procedures of the study, e.g. due to language problems or severely reduced health status * pregnant patients or patients who have disclosed to their physician that they are planning a pregnancy in the near future * hyperphenylalaninaemia or mild forms of pku or other inborn errors associated with elevated phe but not requiring dietary and / or pharmacological treatment according to locally applied guidelines * no inform
a prospective evaluation of microwave ablation (mwa) in the treatment of relapsed graves' disease

Conditions: Graves Disease; Minimally Invasive Treatment; Ablation Treatment

Summary: graves' disease is the most common cause of hyperthyroidism, with conventional treatment options being anti-thyroid drugs (atd), radioiodine (rai) and surgery. for atd, it has been the first-line treatment over decades. despite its ability to induce remission, minor side effects such as skin rash, gastrointestinal disturbance and arthralgia occur in around 5% of patients, while serious adverse reactions including agranulocytosis and hepatotoxicity are potentially life threatening. patients are usually treated with atd for 12 to 18 months but the relapse rate was reported to be up to 50-60% which these patients would require more definitive treatment options with rai or thyroidectomy. however, rai is not preferable in patients with graves' ophthalmopathy as it could further worsen eye symptoms. rai may also cause hypothyroidism in a substantial proportion of patients, with a subsequent need for lifelong thyroxine replacement. as for thyroidectomy, it carries an overall 2-10% risk of complications including bleeding, transient or permanent recurrent laryngeal nerve injury and hypoparathyroidism. due to the drawbacks of the various conventional treatment options, there has been increasing interest in the development of minimally invasive treatment alternatives in recent years. with the evolution of thermal ablative strategies, high-intensity focused ultrasound (hifu) and radiofrequency ablation (rfa) have been reported as feasible treatment options for relapsed graves' disease. there has also been increasing reports in the use of microwave ablation (mwa) in the treatment of benign thyroid nodules. mwa works via generation of electromagnetic field and is performed by inserting a microwave antenna into the thyroid gland percutaneously under ultrasound (usg) guidance. the active tip of the antenna causes oscillation of the surrounding water molecules which induces frictional heat and creates a thermal ablative effect. as compared to rfa, mwa is not affected by heat sink effect and may require a shorter treatment time. similar to other thermal ablative approaches, mwa has the merits of avoiding surgical scar, organ preservation as well as being an ambulatory procedure.


Eligibility criteria:
inclusion criteria: * (a) age older than 18 years, * (b) relapsed graves' disease despite an adequate atd treatment for 18 months or more * (c) absence of vocal cord immobility exclusion criteria: * (a) patients who prefer or are indicated for surgery, * (b) presence of head and/or neck disease preventing hyperextension of the neck, * (c) history of thyroid cancer or other malignant tumours in the neck region, * (d) history of neck irradiation, * (e) severe graves' ophthalmopathy, * (f) large compressive goitre, * (g) pregnancy or lactation, and * (h) any contraindication to intravenous sedation.

Keywords: graves disease thyroid function remission non surgical
role of lung ultrasound and pulsed-wave doppler in lung consolidations in mechanically ventilated patients

Conditions: Atelectasis; Pneumonia

Summary: in infectious lung consolidations, the inhibition of hypoxic pulmonary vasoconstriction (hpv) results in a higher regional acceleration time (ract) compared to the ract measured in atelectatic consolidations.

ventilator-associated pneumonia has a considerable impact on morbidity and mortality in intensive-care patients. chest radiography, which is the most frequently used imagery test for bedside lung evaluation in mechanically ventilated patients, is recognized to be poorly sensitive and non-specific for the diagnosis of ventilator-associated pneumonia. bronchoalveolar lavage using a bronchoscope remains the most reliable tool for the diagnosis of this nosocomial infection. however, a bronchoscopy may not be feasible in all patients and waiting time before final results become available may cause a delay in the initiation of the treatment, thus increasing the risk of mortality. lung ultrasound is a promising non-invasive, non-radiant, portable and easy to use tool especially in critically-ill patients. dependent atelectasis is a frequent phenomenon in mechanically ventilated patients. the presence of clinical infection signs raises the question of the nature of the infiltrate. a consolidation of infectious nature differs from atelectasis by its local hypoxic pulmonary vasoconstriction inhibition. in patients breathing spontaneously, it is possible to detect this difference using the ract, measured by pulsed-wave doppler in an arterial blood vessel located in a pulmonary consolidation visible by ultrasound examination. the use of pulsed-wave doppler to measure the ract in a consolidation added to the value of general lung ultrasound could help determine the infectious or atelectatic nature of a consolidation in mechanically ventilated patients. however, the ract has never been studied in patients under positive pressure ventilation. in this observational study, the investigators will explore the role of measuring the ract and of general lung ultrasound as a diagnostic tool to detect pneumonia in mechanically ventilated patients.

Eligibility criteria:
inclusion criteria: * under mechanical ventilation and presenting one or more consolidations on chest radiography or ct scan exclusion criteria: * participation to another study * poor echogenicity (morbid obesity, multiple thoracic dressings) * contra-indications to superior limbs or torso mobilization * contra-indications to bronchoscopy * antibiotics initiated more than 24 hours but less than 72 hours before inclusion or changes in the antibiotic regimen in the last 72 hours.

Keywords: atelectasis pneumonia lung ultrasound doppler
circulating tumor cells and melanoma: comparing the epispot and cellsearch techniques

Conditions: Metastatic Melanoma

Summary: the main objective of this study is to compare results for the detection of circulating melanoma cells (cmc) using cellsearch versus epispot (epithelial immunospot) techniques between a group of patients with metastatic melanoma and a group of hospitalized control patients.

the secondary objectives of this study include: a. to compare the following elements between the two patient groups: * the number of cmcs per ml of blood as determined by epispot * the number of cmcs per ml of blood as determined by cellsearch * the percentage of patients with at least 2 cmcs per ml of blood according to the two techniques * the % of cmcs expressing ki67 * the % of cmcs expressions s100 (only the epispot technique) b. to compare the epispot and cellsearch techniques is terms of the following: * the number of cmcs detected per ml blood * the number of cmcs expressing antigen ki67 c. to re-evaluate the 2-cmc per ml blood threshold

Eligibility criteria:
inclusion criteria: * the patient must have given his/her informed and signed consent * the patient must be insured or beneficiary of a health insurance plan * the patient is available, within the hours of his/her normally scheduled medical care, for blood sampling at 8 am and 4 pm on the same day. inclusion criteria for patients: * stage 4 melanoma, without other associated neoplasms inclusion criteria for controls: * patient without cancer, nor history of cancer exclusion criteria: * the patient is participating in another study * the patient is in an exclusion period determined by a previous study * the patient is under judicial protection, under tutorship or curatorship * the patient refuses to sign the consent * it is impossible to correctly inform the patient * the patient is pregnant, parturient, or breastfeeding * the patient has a contra-indication for a treatment used in this study exclusion criteria for patients: * stage 1 to 3 melanoma, or other types of cancer exclusion criteria for controls: * history of cancer

Keywords: epispot cellsearch circulating melanoma cells circulating cells
evaluation of coldzyme® mouth spray on prevention and alleviation of rhinovirus induced common cold

Conditions: Common Cold

Summary: this study evaluates the performance of coldzyme® mouth spray on prevention and alleviation of induced rhinovirus upper respiratory tract infection in healthy volunteers. half of participants will receive coldzyme® mouth spray while the other half will receive placebo.

common colds can be caused by a number of viruses, e.g. rhinoviruses, coronaviruses, influenza viruses and others. the majority of colds are however caused by rhinovirus infection, which is responsible for up to 80% of all common colds. this study evaluates the effect of creating a physical barrier on the pharyngeal mucosal membrane to prevent or reduce virus cell entry during common cold infection to reduce total virus load and common cold symptoms in vivo in relation to placebo.

Eligibility criteria:
inclusion criteria: 1. healthy male or female subjects between 18-65 years. the investigator judges the definition of healthy by detailed medical history and physical examination. 2. females of childbearing potential: should use reliable method of birth control. reliable methods are hormonal contraceptives (combination pills, injections or implants), intrauterine device, condom or declared absence of sexual contact. post-menopausal woman is defined as absence of menstrual discharge for at least two years. 3. signed informed consent form prior to any study-related procedures. 4. willingness and ability to complete the study. 5. perceived to have had at least one cold per year. exclusion criteria: 1. smoker, during the last 12 months. 2. any cold symptom within the last month such as sore throat, sneezing, rhinorrhoea, malaise, nasal obstruction or cough. 3. presence of serum neutralising antibodies against human rhinovirus16 at screening. 4. active allergic rhinitis, asthma or chronic obstructive pulmonary disease in last year. 5. positive for fur allergy (if subject is likely to come in contact with the specific pet) and/or dust-mite allergy in skin prick test at screening. 6. nasal disease, e.g. nasal polyposis, significant septal deviation, chronic rhinosinusitis, etc. 7. females: pregnant, breast-feeding or intentions to become pregnant during the study. 8. active autoimmune disease in last year. 9. evidence or history of drug or alcohol abuse. 10. use of any prescribed or non-prescribed medication (except for contraceptives, paracetamol and ibuprofen) within 2 weeks prior to the first administration of investigational product until the end of study. 11. use of any over the counter cold prophylaxis products such as c-vitamins, zinc or echinacea within 1 month prior to the first administration of investigational product until the end of study. 12. participation in other clinical study within 60 days
all2008 protocol for childhood acute lymphoblastic leukemia (all) - 6mp consolidation therapy

Conditions: Acute Lymphoblastic Leukemia

Summary: the purpose of this study is to increase the fraction of patients, who become mrd-negative during consolidation for the non-hr all group through individualized intensification of the 6mp-dosage days 30-85.

20% of children with all still fails to be cured. the all-2008 protocol is a treatment and research protocol that aims to improve the overall outcome of nordic children and adolescents with all in comparison with the all-2000 protocol and previous nopho protocols. the specific and primary objectives of the randomised study is: to increase the fraction of patients, who become mrd-negative during consolidation for the non-hr all group through individualised intensification of the 6mp-dosage days 30-85. we will additionally measure efs and toxicity as secondary end points of effect.

Eligibility criteria:
inclusion criteria: * childhood all * all mandatory biological data are available6 * written informed consent has been obtained exclusion criteria: * mixed lineage all * pre-treatment with glucocorticosteroids or other antileukemic agents for more than 1 week * all predisposition syndromes * previous cancer * off protocol administration of additional chemotherapy during induction therapy * sexually active females not using contraception * tpmt-deficiency

Keywords: acute lymphoblastic leukemia child 6-mercaptopurine minimal residual disease efficacy childhood acute lymphoblastic leukemia
safety and efficacy of litramine in overweight and obese subjects

Conditions: Overweight; Obesity; Weight Loss

Summary: preparations that bind to nutritional fat and inhibit its absorption could be decisively meaningful for the regulation of bodyweight or obesity. further, it is known that soluble fibres gel and swell in the stomach and thereby induce a feeling of satiety or fullness after eating. such effects are supposed to facilitate adherence to energy-restricted diets. the medical device to be investigated contains a patented formula of fibre complex having a high ability to bind to dietary fat. therefore, the rationale for this study is to confirm that litramine's proven fat binding capacity to increase fat excretion and modulate the feeling of satiety will translate into measurable reduction in body weight. a double blind, randomized, placebocontrolled design has been chosen to assess the efficacy and safety of litramine in overweight and obese subjects on a energy-restricted diet.


Eligibility criteria:
inclusion criteria: * 25 ≤ bmi ≤ 35 * expressed desire for weight loss * accustomed to 3 main meals/day * consistent and stable body weight 3 months prior to study enrolment * commitment to avoid the use of other weight loss products during study * commitment to adhere to diet recommendation * females' agreement to use appropriate birth control methods during the active study period * subject declares in writing his/her consent to participate, understands requirements of the study and is willing to comply exclusion criteria: * known sensitivity to the ingredients of the device * presence of any active gastrointestinal disease * malabsorption disorders (e.g. coeliac disease) * pancreatitis * stenosis in the gi tract * bariatric surgery * abdominal surgery within the last 6 months prior to the study * history of eating disorders like bulimia, anorexia nervosa * history of renal disease * history of nephrolithiasis * history of cardiac diseases * osteoporosis * other serious organ or systemic diseases such as cancer, hiv, or diabetes mellitus * any medication that could influence gi functions such as antibiotics, laxatives, opioids, anticholinergics, or anti-diarrheals (must have stopped 3 months before study start) * pregnancy or nursing * any medication or use of products for the treatment of obesity (e.g., orlistat, other fatbinder, fatburner, satiety products etc.) * more than 3 hours serious sport activity per week * history of abuse of drugs, alcohol or medication * smoking cessation within the 6 months prior to this study * inability to comply due to language difficulties * participation in similar studies or weight loss programs within the 6 months prior to this study * participation in other studies within the last 4 weeks

Keywords: overweight obesity weight loss body fat waist circumference satiety
effectiveness of dims spectacle as a function of the age

Conditions: Myopia

Summary: purpose: to evaluate the effectiveness of defocus incorporated multiple segments (dims) in slowing myopia progression as a function of age in pediatric patients. methods: this was a non-randomized experimenter-masked retrospective controlled observational study of european individuals aged 6 -16 years with progressive myopia but no ocular pathology. the charts of the participants allocated to receive dims spectacles (hoya® miyosmart®) or single vision spectacle lenses (control group) were retrospectively reviewed. the key outcome variables, cycloplegic spherical equivalent (se) and axial length (al), were measured at baseline and at 36 month follow up. the results were stratified by age into four groups: patients that wore dims spectacles oldest or youngest than 10 years (respectively, group a, 20 patients mean age 13.6±2.2 and group c, 20 patients mean age 9.0±1.2) and age matched control groups (group b, 18 patients mean age 13.2±2.5 and group d, mean age 8.5±0.9).

participants were allocated to the study groups, receiving dims spectacles, or to the control groups, wearing single vision spectacle lenses.

Eligibility criteria:
inclusion criteria: * patient age between 6-16 years * progressive myopia with cycloplegic spherical equivalent (se) from -0.50 to -4.00 diopters (d) * astigmatism less than 2.50d, anisometropia under 1.25d exclusion criteria: * genetic syndromes suspected (e.g., stickler, marfan, etc.) * systemic diseases * eye diseases (such as glaucoma, juvenile cataracts, retinal abnormalities, any form of strabismus)